Genentech, Inc. said it has received notification from the US Patent and Trademark Office that a final Office action has been issued and mailed rejecting the patentability of claims of the Cabilly patent, et al. US Patent No. 6,331,415 ('415 patent).
The company has not received the Office action but anticipates that it will file a response to this final Office action upon review of the document. Should the rejection be maintained, the company will appeal the decision to the Board of Appeals within the Patent Office.
The '415 patent remains valid and enforceable through the appeals process. The company estimates that the entire appeals process may take approximately one to two years, or longer.
It is expected that the Patent Office will make a copy of the final Office action available to the public on its website. The decision covers two separate reexaminations of the '415 patent that the Patent Office initiated based on requests received from third parties, and that were later merged into one proceeding.
The '415 patent relates to certain methods used to make antibodies and antibody fragments by recombinant DNA technology, as well as recombinant cells and DNA that are used in those methods. Genentech utilizes this technology for many of its own products and has confidential licensing agreements with a number of companies on the '415 patent. Genentech and the City of Hope receive revenue under such license agreements including royalties on sales of products that are covered by one or more claims of the patent.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercialises biotherapeutics for significant unmet medical needs. Genentech manufactures and commercializes.